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Articles in the FDA Category

FDA, Headline, Prescription Drugs »

[13 Jul 2010 | Comments Off | 26 views]
Diabetes Drug Avandia : Drug Maker’s Study Under Investigation

The New York Times reported this week that GlaxoSmithKline, the maker of Avandia, a prescription drug intended for the treatment of Type 2 diabetes, undertook a secret study in 1999 that it has attempted to keep unknown for the past 11 years.

FDA, Prescription Drugs »

[2 Jul 2010 | Comments Off | 58 views]
Diabetes Drug Avandia and Strokes and Heart Attacks: Further Evidence of Link

The Los Angeles Times reported that the prescription diabetes drug, Avandia, is linked with an increased risk of hearts attacks, heart failure and strokes, as released in two independent recent study findings.

FDA, Prescription Drugs »

[20 Feb 2010 | Comments Off | 85 views]
Avandia Diabetes Drug And Patient Heart Attacks Linked, New York Times Reports

Confidential government reports disclosed to the New York Times recommend that the diabetes drug Avandia be removed from the market because of the significant risk of heart attacks and the availability of a safer alternative drug.

FDA, Headline, Litigation, Medical Devices »

[4 Feb 2010 | Comments Off | 121 views]
Medtronic Heart Lead Recall Update: “[Sprint] Fidelis lead fracture rate is increasing exponentially with time”

In March 2009, Medtronic disclosed that at least 13 Sprint Fidelis patients may have died, including four patients whose deaths were related to efforts by doctors to surgically remove the product. In February 2010, the Wall Street Journal reported that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device.

FDA, Prescription Drugs »

[8 Jan 2010 | Comments Off | 57 views]
Aranesp, Epogen and Procrit Anti-Anemia Drugs Linked to Strokes and Heart Attacks

Facing evidence of increased risks of stroke and heart attack among patients using high doses of certain anti-anemia drugs, the FDA has announced it will ask outside experts to re-examine the safety and proper dosage of Aranesp, Epogen and Procrit

FDA, Medical Devices »

[30 Dec 2009 | Comments Off | 5 views]
Studies spotlight problems in FDA device approvals for devices like pacemakers, heart stents

Two new studies find shortfalls in the Food and Drug Administration’s approval process for heart devices such as pacemakers and stents

FDA, Featured, Prescription Drugs »

[18 Dec 2009 | Comments Off | 18 views]
Medical Dyes for MRIs and Link to Nephrogenic Systemic Fibrosis (NSF)

Exposure to certain medical dyes used in MRIs has been linked to the development of the debilitating disease Nephrogenic Systemic Fibrosis

FDA, Featured, Prescription Drugs »

[13 Dec 2009 | Comments Off | 57 views]
Reglan’s Dangerous Side Effect: Tardive Dyskinesia

The prescription drug Reglan has been linked to Tardive Dyskinesia (TD), a neurological disorder which can include involuntary spasms and movements.

FDA, Prescription Drugs »

[10 Dec 2009 | Comments Off | 5 views]
GAO: FDA yet to make safety changes post-Vioxx scandal

The FDA still hasn’t restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal

FDA, Medical Devices »

[18 Nov 2009 | Comments Off | 1 views]
Medtronic gets FDA warning on documentation, responses, quality control in heart implant unit

The FDA found problems with procedures for preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues